Junior CSV Specialist: Life Sciences Validation

MAASI Enterprises Ltd; Emilia-Romagna; Ibrido; EUR 27.000 - 36.000; Tempo pieno

Vantaggi offerti da questo lavoro

Performance bonuses

Training programs

Equal opportunities

Descrizione del lavoro

MAASI Enterprises Ltd seeks a Junior Computerised System Validation (CSV) Specialist in the Imola area to join client-facing consulting projects in Life Sciences. Graduates or those with minimal experience are welcome to build a career in validation and regulated environments.

You will assist with Validation Plans, IQ/OQ/PQ tests, and final reports, working under senior guidance and ensuring GxP/GAMP 5 compliance. Italian and English proficiency is required; travel is at least 30%.

Competenze

• Bachelor’s or Master’s degree in Engineering or STEM disciplines with good GxP awareness.
• Native/fluent Italian and strong English (CEFR B2/C1) for drafting and multinational liaising.
• Methodological rigour, precise documentation, and proactive teamwork in regulated environments.

Mansioni

• Assist with preparation of software lifecycle deliverables (Validation Plans, Validation Reports, Traceability Matrices, URS).
• Support test protocols (IQ, OQ, PQ) for computerised systems in pharma processes.
• Review FS/DS with technical teams and update SOPs/WIs for validated systems.
• Contribute to data collection for risk assessments and impact analyses.

Conoscenze

GxP knowledge

Documentation drafting

Formazione

Bachelor’s or Master’s degree in Engineering (Biomedical, Management, Computer Science, Chemical), Biotechnology, Pharmaceutical Chemistry and Technology

Descrizione del lavoro

MAASI Enterprises Ltd seeks a Junior Computerised System Validation (CSV) Specialist in the Imola area to join client-facing consulting projects in Life Sciences. Graduates or those with minimal experience are welcome to build a career in validation and regulated environments.

You will assist with Validation Plans, IQ/OQ/PQ tests, and final reports, working under senior guidance and ensuring GxP/GAMP 5 compliance. Italian and English proficiency is required; travel is at least 30%.